FDA LETTER LIBRARY

FDA application & warning letters

Name: FDA Approval, Complete Response & Warning Letters
Creator: Assyro AI
License: https://www.usa.gov/government-works

Review 1,819 source-backed approval, tentative approval, complete response, and warning letters. Application letters cover 2026; the CRL corpus is complete as published by openFDA, and warning letters cover 2026.

Showing 1033-1044 of 1819 letters

TATentative Approval Letter
Tentative Approval Letter AUROBINDO PHARMA LIMITED (Jun 5, 2026)
FDA posted a tentative approval letter for CENOBAMATE on 2026-06-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219473 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 5, 2026
US FDA• CENOBAMATE
ALApproval Letter
Approval Letter MSD SUB MERCK (Jun 5, 2026)
FDA posted an approval letter for STEGLUJAN on 2026-06-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209805 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 5, 2026
US FDA• STEGLUJAN
TATentative Approval Letter
Tentative Approval Letter HETERO LABS LIMITED (Jun 5, 2026)
FDA posted a tentative approval letter for CYCLOPHOSPHAMIDE on 2026-06-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219271 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 5, 2026
US FDA• CYCLOPHOSPHAMIDE
ALApproval Letter
Approval Letter ASTRAZENECA AB (Jun 5, 2026)
FDA posted an approval letter for FASENRA on 2026-06-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761070 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 5, 2026
US FDA• FASENRA
ALApproval Letter
Approval Letter MSD SUB MERCK (Jun 5, 2026)
FDA posted an approval letter for STEGLATRO on 2026-06-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209803 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 5, 2026
US FDA• STEGLATRO
ALApproval Letter
Approval Letter ASTRAZENECA AB (Jun 5, 2026)
FDA posted an approval letter for FARXIGA on 2026-06-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202293 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 5, 2026
US FDA• FARXIGA
ALApproval Letter
Approval Letter ASTRAZENECA AB (Jun 5, 2026)
FDA posted an approval letter for QTERN on 2026-06-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209091 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 5, 2026
US FDA• QTERN
ALApproval Letter
Approval Letter SANDOZ (Jun 5, 2026)
FDA posted an approval letter for ARGATROBAN IN DEXTROSE on 2026-06-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 201743 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 5, 2026
US FDA• ARGATROBAN IN DEXTROSE
ALApproval Letter
Approval Letter JANSSEN PHARMS (Jun 5, 2026)
FDA posted an approval letter for INVOKANA on 2026-06-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204042 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 5, 2026
US FDA• INVOKANA
ALApproval Letter
Approval Letter THERACOSBIO (Jun 5, 2026)
FDA posted an approval letter for BRENZAVVY on 2026-06-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214373 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 5, 2026
US FDA• BRENZAVVY
WLWarning Letter
Warning Letter Imu-Tek Animal Health, Incorporated (Jun 5, 2026)
FDA issued a warning letter to Imu-Tek Animal Health, Incorporated concerning Dietary Supplement/New Drug/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJun 5, 2026
US FDA• Dietary Supplement/New Drug/Misbranded
WLWarning Letter
Warning Letter Mineral BioSciences, LLC (Jun 5, 2026)
FDA issued a warning letter to Mineral BioSciences, LLC concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJun 5, 2026
US FDA• Unapproved New Drugs/Misbranded

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Tentative Approval Letter AUROBINDO PHARMA LIMITED (Jun 5, 2026)

Approval Letter MSD SUB MERCK (Jun 5, 2026)

Tentative Approval Letter HETERO LABS LIMITED (Jun 5, 2026)

Approval Letter ASTRAZENECA AB (Jun 5, 2026)

Approval Letter MSD SUB MERCK (Jun 5, 2026)

Approval Letter ASTRAZENECA AB (Jun 5, 2026)

Approval Letter ASTRAZENECA AB (Jun 5, 2026)

Approval Letter SANDOZ (Jun 5, 2026)

Approval Letter JANSSEN PHARMS (Jun 5, 2026)

Approval Letter THERACOSBIO (Jun 5, 2026)

Warning Letter Imu-Tek Animal Health, Incorporated (Jun 5, 2026)

Warning Letter Mineral BioSciences, LLC (Jun 5, 2026)